NCT02416206

High Dose Chemotherapy Using BeEAM for Autologous Transplant in Multiple Myeloma

Completed Phase 2 Results posted Last updated 18 May 2023

What this trial tests

Phase 2 trial testing BeEAM in Multiple Myeloma in 65 participants. Completed in 21 April 2021.

Timeline

27 April 2015

Primary endpoint
26 March 2020

21 April 2021

Quick facts

Lead sponsor	Northside Hospital, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	65
Start date	27 April 2015
Primary completion	26 March 2020
Estimated completion	21 April 2021
Sites	1 location across United States

Drugs / interventions tested

• BeEAM

Conditions studied

• Multiple Myeloma — all drugs for Multiple Myeloma →

Sponsor

Northside Hospital, Inc.

Who can join

Adults 18 to 70, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

To Estimate the Response at Day 100 Following Transplant (Rate of CR) Primary · Day 100

Using IMWG criteria: PR (partial response) noted as \>50% reduction of serum M-protein and reduction in 24hr urinary M-protein by \>90% or to \<200mg/24h; VgPR (very good partial response) noted as serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>90% reduction in serum M-protein plus urine M-protein level \<100mg/24h; CR (complete response) noted as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow; sCR (stringent complete response) noted as CR defined above plus normal FL

Group	Value	95% CI
BeEAM	26
BeEAM	32
BeEAM	7

Number of Patients With Overall Survival Post-transplant Secondary · 3 years

Group	Value	95% CI
BeEAM	60

Number of Patients With Progression-free Survival Secondary · 3 years

Group	Value	95% CI
BeEAM	37

Number of Patients Who Relapsed After Transplant Secondary · 3 years

Group	Value	95% CI
BeEAM	28

Adverse events — posted to ClinicalTrials.gov

Time frame: Deaths were assessed up to 3 years. Adverse events were assessed up to 3 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

BeEAM

Serious: 48/65 (74%)

Deaths: 5/65

Serious adverse events (2 terms)

Reaction	System	BeEAM
neutropenic fever	Investigations	—
Esophagitis	Gastrointestinal disorders	—

Other adverse events (2 terms — click to expand)

Reaction	System	BeEAM
hypertension	Cardiac disorders	—
peripheral neuropathy	Nervous system disorders	—

Most-reported serious reactions: neutropenic fever, Esophagitis.

Data from ClinicalTrials.gov NCT02416206 adverse events section.

Sponsor's own description

High-dose chemotherapy and autologous stem cell transplantation (ASCT) as part of the up-front treatment of patients with multiple myeloma has been associated with improved disease-free and overall survival in multiple large randomized controlled trials. Following 3-6 cycles of standard induction therapy with biologic agents, consolidation with high dose Melphalan and ASCT has become the standard-of-care approach for fit myeloma patients up to 70 years of age. Single-agent high-dose Melphalan (200mg/m2) is currently the standard-of-care preparative regimen prior to autologous transplant in Myeloma. Historical studies utilizing Busulfan- or Total Body Irradiation-based preparative regimens have yielded similar results to single-agent Melphalan with higher toxicity.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Cancer Stem Cells: Metabolic Characterization for Targeted Cancer Therapy.
   Kaur J, Bhattacharyya S. · · 2021 · cited 21× · PMID 34804950 · DOI 10.3389/fonc.2021.756888